Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01131546
First received: May 25, 2010
Last updated: May 30, 2011
Last verified: May 2011

May 25, 2010
May 30, 2011
December 2009
March 2011   (final data collection date for primary outcome measure)
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01131546 on ClinicalTrials.gov Archive Site
  • Change from baseline in systolic blood pressure (SBP) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in diastolic blood pressure (DBP) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Incidence of adverse effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension
A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension

This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Levamlodipine besylate
    Once daily, 7AM - 10AM
  • Drug: Amlodipine maleate
    Once daily, 7AM - 10AM
  • Experimental: Levamlodipine besylate (2.5mg)
    Intervention: Drug: Levamlodipine besylate
  • Experimental: Levamlodipine besylate (5mg)
    Intervention: Drug: Levamlodipine besylate
  • Active Comparator: Amlodipine maleate (5mg)
    Intervention: Drug: Amlodipine maleate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1080
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients, 18-75 Years
  • Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and < 180mm/110mmHg)
  • Written informed consent

Exclusion Criteria:

  • Patients with secondary hypertension
  • Patients with severe hypertension
  • Have to take other drugs that can influence blood pressure during the study
  • Allergic to DHP calcium antagonists
  • Evidence of congestive heart failure, unstable angina or severe arrhythmia
  • Renal or hepatic dysfunction
  • Women who are taking contraceptive pills or are likely to be pregnant
  • Participate in other clinical trials within 3 months prior to this study
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01131546
SIM-77
No
Jinsheng Ren, Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Dayi Hu, MD Peking University People's Hospital
Principal Investigator: Jinming Yu, Ph.D. School of Public Health, Fudan University
Jiangsu Simcere Pharmaceutical Co., Ltd.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP